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510(k) Data Aggregation

    K Number
    K992252
    Device Name
    LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965
    Manufacturer
    CHEMICON INTL., INC.
    Date Cleared
    1999-08-10

    (35 days)

    Product Code
    LYF
    Regulation Number
    866.3780
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHEMICON INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Light Diagnostics Pneumocystis carinii DFA intended use is an in vitro procedure for the detection of Pneumocystis carinii cysts and trophozoites in direct smears of respiratory tract specimens including sputum, bronchoaveolar lavage, and lung biopsy.
    Device Description
    Not Found
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